Levaquin Litigation MDL

Mass Tort Litigation has emerged as the only effective check on pharmaceutical and medical device companies that make dangerous products injuring thousands of Americans. Mass tort attorneys have filed 140,000 lawsuits in 250 federal multidistrict litigation dockets as of September 2016.

Many attorneys are expanding their personal injury practices to include mass torts because the US Judicial Panel on Multidistrict Litigation has organized the litigation so effectively against the multi-billion-dollar drug and medical device industry.

“The FDA is not a check or a balance on the pharmaceutical industry,” said Mass Tort Nexus Consultant John Ray, recently teaching a four-day course about mass torts in Fort Lauderdale, FL. “Plaintiff attorneys are the only check on the pharmaceutical industry.”

In recent years mass tort lawyers have recovered $10 billion in settlements for injured Americans: $4.8 billion for Vioxx, $1.8 billion for Yaz, $1.3 billion for the Stryker hip and $2.5 billion for the DePuy hip.

“The drug companies bake these cases into their business model,” Ray said. “Defendants call it a win when they don’t put a warning on their labels, don’t get sued and don’t have to pay a judgment at all. This means they got away with it. That happens a lot.”

When a federal MDL is created, the supervising judge will approve a standard short-form or long-form complaint, plus a plaintiffs’ fact sheet which replaces interrogatories. The consolidation of cases means that a mass tort lawyer can file a notice of appearance and file cases regardless of the jurisdiction of the plaintiff, defendant company or the location of the plaintiff’s attorney.

Criteria for a viable case

Cases that are attracting many mass tort attorneys now involve Xarelto, IVC filters and Pradaxa. Among the many factors determining the viability of a mass tort are:

Statute of limitations: State laws govern when the statute of limitations starts to run, but in most federal litigation, the date that the FDA issues a “black box warning” for a drug marks the date when the time limit begins to run.

Legal viability. In many cases, research will show a connection between a drug and injuries among patients, but specific causation must be proved in a trial. Experts must be found who will survive a Daubert motion to disqualify.

Financial viability of the defendant. While Johnson & Johnson had $46.8 billion in annual income in 2015, some small makers of IVC filters went out of business before they could sell one.

Cost per client acquired. Costs can add up with Facebook advertising, website marketing, and lead generation companies. For example, The Sentinal Group will advertise for clients for a fee of $100,000 to obtain 250 calls for Xarelto plaintiffs, with 1 out of 5 calls leading to a signed client.

Case duration. Mass torts are litigation for the long haul, with the average case lasting 5 years and 4 months before settlement, according to Ray, with 7 years being a good benchmark for the duration of a case.

Case value. An example of a good outcome is with Pradaxa. The average settlement is $162,000. Calculating 40% in gross contingent fees would equal $64,800. Another 7% is deducted ($4,536) for the common benefit to pay the steering committee. Of the remaining fee of $60,204, a 40% referral fee of $24,015 is deducted for the co-counsel that handled the litigation. This leaves a net fee of $36,189 for the attorney who originated the case.

Financial resources. Costs to fund a case can be in the tens of thousands of dollars, with costs reaching hundreds of thousands for members of the plaintiffs steering committee.

Personnel resources. A law firm will have to train a small army of intake specialists to answer incoming calls when advertising is running. Additional personnel will be needed to obtain and review medical records.

Perfect timing

There are three phases of mass tort litigation, and perfect timing will be needed to enter a particular case.

Emerging Phase Cases. In this early phase, the cost to acquire a client is the least expensive, but there many issues of case viability. For example, the courts are still considering motions to consolidate cases involving Abilify and Roundup. With Abilify the FDA has issued a safety warning but not a black box warning. With Roundup the EPA has not classified the herbicide as a carcinogen, but foreign governments have.

Litigation Phase Cases. It is considered an ideal time to enter into a mass tort when the JPML has created a multi-litigation docket (MDL). Some 250 MDLs include mature litigation involving Benicar, Lipitor, Viagra, Xarelto and Zofran, and many legal issues have been settled. The supervising judge will schedule bellwether or test cases for trial.

Settlement Phase Cases. This is the very safest time to enter litigation because all an attorney must do is find qualified plaintiffs. Example cases involve transvaginal mesh, Levaquin and Pradaxa. However at this late phase the cost to acquire a client is at its highest.

“Whatever you do, maintain your single-event plaintiff’s practice,” Ray advised. “You will have to keep paying the costs of a mass tort case until it settles, and you will need a huge cash supply or credit line.”

A woman who used the antibiotic Levaquin and developed permanent nerve damage has filed a class action lawsuit accusing Janssen Pharmaceuticals of failing to adequately warn patients and doctors about the risk of severe nerve damage from Levaquin.

The lawsuit (PDF) was filed on August 11 by Michelin Rowell, a woman from North Carolina who was diagnosed with peripheral neuropathy. She is seeking class action status on behalf of everyone who was injured.

The case is Rowell v. Johnson & Johnson et al, Case No. 2:16-CV-04369 in the U.S. District Court for the Eastern District of Pennsylvania. The plaintiff argues that the running of any statute of limitations has been tolled by reason of Defendants’ fraudulent concealment of risks associated with
Levaquin.

State and federal litigation

Nearly 400 peripheral neuropathy lawsuits filed against the manufacturers of Levaquin, Cipro and Avelox continue are pending in Levaquin Litigation MDL 1943 in U.S. District Court in Minnesota.

Additional claims with similar allegations regarding the potential for fluoroquinolone antibiotics to cause peripheral neuropathy and permanent nerve damage have been filed in the Philadelphia Court of Common Pleas.

The defendants include Bayer (Cipro and Avelox), Janssen (Levaquin), and McKesson (a distributor).

Peripheral neuropathy was added to the label in 2004, but Janssen said nerve damage was a “rare” side effect that would go away when Levaquin was discontinued. The problem is that studies dating back to 2001 concluded that symptoms usually developed within a week, and in most cases problems persisted for at least one year.

In August 2013, the FDA ordered Janssen to update the label with stronger warnings about peripheral neuropathy. The word “rare” was removed and the new warnings emphasize the rapid onset of symptoms and potentially permanent complications, even if Levaquin is discontinued.

In May 2016, the FDA issued another warning about “disabling” side effects that “generally outweigh the benefits” when Levaquin is prescribed for common infections like sinusitis, bronchitis, and uncomplicated urinary tract infections (UTIs).

The FDA revised the Boxed Warning, its strongest warning, about fluoroquinolone antibacterial drugs to address side effects including permanent damage to the tendons, muscles, joints, nerves, and central nervous system — which can occur together in the same patient.

On July 26, 2016, the FDA identified the specific drugs:

Avelox (moxifloxacin)

Cipro (ciprofloxacin)

Cipro extended-release (ciprofloxacin extended-release)

Factive (gemifloxacin)

Levaquin (levofloxacin)

Ofloxacin (generic brand)

The Fluroroquinolones MDL 2642, which includes complaints related to Levaguin, Cipro and Avelox related to peripherial neruropathy have been transfered to the same court (District of Minnesota) and the same Judge (John R Tunheim) as the Levaquin MDL 1943 related to tendon ruptures.

Cases Pending

Defense counsel reported that there are currently 18 cases pending in the MDL. The DeFelice case is active and in the process of discovery. The Watson case is settled and paperwork is being prepared for dismissal. Ten other cases are waiting for paperwork and will soon be ready for dismissal. Defense counsel reported that in six pending cases, the parties previously reached a settlement, but defense counsel never received final paperwork. Defense counsel sent plaintiffs’ counsel letters requesting that they attend the next status conference. In four out of the six cases, defense counsel successfully made contact with counsel for the plaintiffs, and they hoped to finalize the paperwork soon.

With regard to the remaining two cases, Castillo and Ditolla, defense counsel did not hear back from plaintiffs’ counsel. The Court agreed that defense counsel should prepare the papers for orders to show cause and submit them to the Court.

Defense counsel reported that in six pending cases, the parties previously reached a settlement, but defense counsel never received final paperwork. Defense counsel sent plaintiffs’ counsel letters requesting that they attend the next status conference. In four out of the six cases, defense counsel successfully made contact with counsel for the plaintiffs, and they hoped to finalize the paperwork soon.

Remand/Transferred Cases

Defense counsel reported that of the cases transferred or remanded 52 had settled, 19 were dismissed, and 19 remained open.

In the Tummolo Case, Plaintiff’s counsel Jacqueline Olson stated that a few years ago certain documents were not sent to the defendants, which resulted in dismissal. Olson says =that she would like the case put back on active calendar and intended to apply to have the case restored.

Defense counsel Tracy Van Steenburgh and Cort Sylvester said that the case is currently dismissed and that Plaintiff would need to file a motion to vacate the dismissal, which defense counsel would decide whether to oppose. The Court stated that plaintiff should file a motion to vacate with supporting reasons within the next two weeks, after which the defense counsel would have an opportunity to respond.

Black Box Warning

The FDA also updated other parts of the drug label including the Warnings and Precautions and Medication Guide sections.

The agency is continuing to assess safety issues with fluoroquinolones as part of its ongoing review of drugs and will update the public if additional actions are needed. See the FDA Drug Safety Communication for additional information, including a Data Summary and Additional Information for Health Care Professionals and Patients.

The labels of fluoroquinolone medicines already have:

A Boxed Warning for tendinitis, tendon rupture, and worsening of myasthenia gravis.

Warnings about the risks of peripheral neuropathy and central nervous system effects.

Labels that warn of other serious risks such as cardiac, dermatologic, and hypersensitivity reactions.

After FDA’s 2013 review that led to the additional warning that peripheral neuropathy may be irreversible, it evaluated post-marketing reports of apparently healthy patients who experienced disabling and potentially permanent side effects involving two or more body systems after being treated with a systemic fluoroquinolone

FDA has determined that fluoroquinolones should be reserved for use in patients who have no other treatment options for acute bacterial sinusitis, acute exacerbation of chronic bronchitis, and uncomplicated urinary tract infections because the risk of these serious side effects generally outweighs the benefits in these patients. For some serious bacterial infections the benefits of fluoroquinolones outweigh the risks, and it is appropriate for them to remain available as a therapeutic option.

Patients must contact your health care professional immediately if you experience any serious side effects while taking your fluoroquinolone medicine. Some signs and symptoms of serious side effects include unusual joint or tendon pain, muscle weakness, a “pins and needles” tingling or pricking sensation, numbness in the arms or legs, confusion, and hallucinations. Talk with your health care professional if you have any questions or concerns (see the List of Serious Side Effects from Fluoroquinolones in the FDA Drug Safety Communication).

Healthcare professionals should not prescribe systemic fluoroquinolones to patients who have other treatment options for acute bacterial sinusitis (ABS), acute bacterial exacerbation of chronic bronchitis (ABECB), and uncomplicated urinary tract infections (UTI) because the risks outweigh the benefits in these patients. Stop fluoroquinolone treatment immediately if a patient reports serious side effects, and switch to a non-fluoroquinolone antibacterial drug to complete the patient’s treatment course.

The proceeding convened its most recently monthly Status Conference, when it was reported that 383 cases were pending in the federal litigation. An addition 39 claims that put forth similar allegations regarding the potential for fluoroquinolone antibiotics to cause peripheral neuropathy and permanent nerve damage have been filed in the Philadelphia Court of Common Pleas.

The involved manufacturers and distributors are Bayer (Cipro and Avelox), Janssen (Levaquin), and McKesson (a distributor).

Fluoroquinolone Side Effects

Fluoroquinolone antibiotics, including Levaquin, Cipro and Avelox, are indicated to treat pneumonia, sexually transmitted diseases, E. coli, staph and other serious bacterial infections. Plaintiffs who have Levaquin lawsuits or other cases pending in the District of Minnesota claim that the manufacturers of these medications failed to provide doctors and patients with adequate warnings about their potential to cause serious nerve damage, including permanent peripheral neuropathy. Mention of these complications was added to the drugs’ labeling in 2004. However, the U.S. Food & Drug Administration (FDA) ordered their manufacturers to strengthen the labels in 2013 to better reflect the rapid onset of symptoms, as well as the potential for permanence. (In Re: Fluoroquinolone Products Liability Litigation – MDL No. 2642)

Last month, the FDA ordered that further modifications be made to the labels for fluoroquinolone medications, this time updating the boxed warning to state that the risks posed by the drugs outweigh their benefits for patients with certain uncomplicated infections when other treatment options are available. The agency acted after a review confirmed that fluoroquinolone antibiotics are associated with a number of serious side effects, including those involving the tendons, muscles, joints, nerves and central nervous system. These complications are potentially permanent and can occur together, the FDA said.

A group of plaintiffs who were seriously harmed by the antibiotic Levaquin, have filed suit against Johnson & Johnson charging violations of the Racketeering and Corrupt Organizations Act (“RICO”).

The racketeering action, which is filed in the U.S. District Court for the District of Columbia, charges that Johnson & Johnson conspired to criminally influence the Commissioner of the Food & Drug Administration to mislabel and misbrand Levaquin.

The case charges that J&J defrauded consumers in order to acquire and reap financial gain, by:

Driving up or maintaining the price of shares of Johnson & Johnson stock.